Simcyp Animal

A PBPK Modeling Platform for Veterinary and Pre-clinical Drug Research

Simcyp® Animal is a whole-body physiologically-based pharmacokinetic (PBPK) modeling platform for rat, dog, and knock-out mouse. It is based on the Simcyp Simulator with simplified interfaces and well-validated models. Simulations with Simcyp Animal can help identify key data requirements and inform the design of subsequent experiments. It can also increase confidence in in vitro-in vivo extrapolation (IVIVE) before moving to human simulations. Simcyp Animal can be used to:

Assess PK properties

Evaluate formulation and food effects on drug absorption

Predict concentration-time profiles in plasma, tissues and organs

Investigate the formation and kinetics of primary metabolites

Benefits

Increased accuracy: When used in conjunction with the Simcyp Population-based Simulator, Simcyp Animal allows comparison of human and animal data without relying upon allometric scaling, which may not be a valid approach for some parameters.

Save time: Compound import and batch processing capabilities allow large numbers of compounds to be screened quickly and sensitivity analysis to be performed.

Our FDA CRADA

Our five year Cooperative Research and Development Agreement (CRADA) with the FDA’s Center for Veterinary Medicine (CVM), aims to deliver PBPK dog models that streamline veterinary drug product development and evaluation. Due to the inherent flexibility of PBPK models to separate extrinsic and intrinsic factors, this collaboration will investigate the effect of these factors in combination or independently on drug kinetics, such as effect of drug formulation and food on drug exposure in animals. This will facilitate using pharmacokinetic principles to address complex questions associated with designing and interpreting animal safety studies and clinical field studies and enable integrating model predictions with data from safety and effectiveness studies to develop informative product labels.